MAUDE Adverse Event Report: MEDIVATORS INC RAPICIDE PA HIGH LEVEL DISINFECTANT

Model Number ML02-0126

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

User facility stated that personnel observed the disinfectant's shipping box was "wet" and leaking from the corner of the bottle prior to the event.During follow-up discussion it was confirmed that the employee subject of the reported event was not wearing proper ppe, specifically gloves while handling the rapicide pa high level disinfectant.The investigation did not disclose what caused the bottle to leak.The employee was counseled on safety protocols and usage of the spill kit and full ppe while handling the disinfectant.Additional counseling was provided on proper inspection techniques for shipping boxes upon delivery.No additional issues have been reported.

Event Description

The user facility reported an employee obtained a skin burn while handling a leaking bottle of rapicide pa high level disinfectant.The user facility disclosed that no medical treatment was sought or administered.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18856535
• MDR Text Key: 337223677
• Report Number: 2150060-2024-00014
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0126
• Device Catalogue Number: ML02-0126
• Device Lot Number: 586808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1